[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Danisco\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100636582","the-short-sleep-study-100636582",false,"NCT07567560","The Short Sleep Study","The Short Sleep Study: A Non-interventional Study of Fecal Microbiota in Natural Short Sleepers","Inclusion:\n\n1. Men between 20 - 50 years of age and pre-menopausal women between 20 - 45 years of age (inclusive).\n2. Consistent schedule during daytime hours.\n3. Body Mass Index (BMI) 18.5 - 35 kg\u002Fm2 (inclusive).\n4. Good physical and mental health as established by self-reported medical history and evaluated by a study investigator.\n5. Willingness to maintain and record their general habits, eating, and daily activity\u002Fexercise pattern for the study period.\n6. Willingness to maintain typical sleep hygiene patterns (e.g. sleep location, temperature, environment).\n7. Willingness to maintain their current pattern of alcohol consumption for the duration of the study.\n8. Willing and able to participate fully in all aspects of the study and complete all study procedures, including providing signed informed consent.\n9. Willing and able to attend two in-person visits at a trial site\n10. Completes all required procedures (screening questionnaire and ePROs) during the 14-day screening period 10a. Two instances of the sleep diary and Karolinska Sleepiness Scale may be missed by the participant without impacting eligibility\n11. Has regular bowel habits, on at least 5 days a week.\n12. Pittsburgh Sleep Quality Index (PSQI) global score of ≤7 and a sleep efficiency score of ≥80%, self-reported during the screening period. Additionally, no more than one score of 3 is permitted across Question 5 sub-items, and no score of 3 is permitted in Question 10 sub-items, if a bed partner is present\n13. Sleep, on average, 4-5.5 hours per night, verified via participant self-report during the screening period. If the participant's average is within the 4-5.5 hour range but slept more than 5.5 hours on any of the nights their eligibility will be assessed per PI\u002FSponsor discretion. Note: Oura ring data from the run-in period will be reviewed to confirm eligibility based on PI\u002FSponsor discretion.\n14. Report feeling refreshed with no desire to nap during the daytime, with a score of ≤4 on the Epworth Sleepiness Scale (ESS) evaluated during the screening period.\n15. Average KSS Score of 1-3 during the screening period.\n\nExclusion:\n\n1. Ever diagnosed with or self-reports a sleep disorder, including sleep apnea, habitual snoring (defined as loud, persistent snoring 3 or more nights per week), insomnia, narcolepsy, or parasomnias.\n2. Extreme chronotypes, those who regularly go to sleep prior to 8:00pm.\n3. Any current diagnosed or self-reported gastrointestinal disorder, including Crohn's disease, ulcerative colitis, celiac disease, IBS, or functional bowel disorder or chronic heartburn.\n4. Regularly wakes up during the night 5 or more times per night for a cumulative amount of 30 minutes as observed via self-report during the screening period, per PI discretion.\n5. Currently taking medications (including over-the-counter medications) or dietary supplements that, in the investigator's opinion, may affect the participants' microbiome or sleep.\n6. Have taken in the last 3 months medications (including over-the-counter medications) or dietary supplements that, in the investigator's opinion, may affect the participants' microbiome or sleep.\n7. Neurodegenerative diseases (including multiple sclerosis, Parkinson's disease, Alzheimer's disease, dementia).\n8. Recent history (past year) of alcohol abuse or dependence. Defined as regularly drinking more than 12 drinks for females and more than 20 drinks for males per week and based on PI discretion.\n9. Drug abuse or dependence, including consistent recreational substance use such as marijuana.\n10. Binge drinking behavior, defined as 4 or more alcoholic drinks for women or 5 or more alcoholic drinks for men in one sitting on 2 or more occasions, within the past 1 month with final decision per PI discretion.\n11. Recent history (current use or within the past 1 month) of smoking, vaping or other use of nicotine-containing products.\n12. Diagnosed neuropsychiatric disorders or symptoms possibly affecting sleep e.g. (generalized anxiety disorder (GAD), major depressive disorder (MDD), bipolar disorder, schizophrenia)\n13. Any use of systemic antibiotics in the past 3 months. This does not include topical or targeted antibiotic use (ointment, spray, eye drop, ear drop).\n14. Any use of probiotic supplements in the past 2 weeks.\n15. Any use of proton pump inhibitors (PPIs) in the past 2 weeks.\n16. Any use of laxatives or antidiarrheals in the past 4 weeks.\n17. Any use of non-steroidal anti-inflammatory drugs (NSAIDs) for 5 or more consecutive days in the past 4 weeks.\n18. Pregnant or breastfeeding or planning to become pregnant.\n19. Personal circumstances affecting stress or sleep (e.g. serving as a caretaker\u002Frequired to wake up during sleep\u002Fmajor change in personal life). Note: Life situations causing stress or challenges in sleep that are considered shortterm, per PI discretion, may be considered for re-screening 4 weeks after the life situation has resolved, meaning it is no longer causing stress or challenges in sleep.\n20. Planned overnight travel during the study.\n21. Females experiencing perimenopausal or menopausal symptoms, or those who have been diagnosed as perimenopausal or menopausal by a physician.\n22. Any diagnosed condition or undiagnosed symptom which disrupts sleep, including, but not limited to, hyperthyroidism, night sweats, restless legs, or poorly controlled allergic rhinitis.\n23. Varying work schedule and\u002For shift workers who work overnight shifts (e.g. 3rd shift, working late night to early morning hours).\n24. Any other personal or medical condition that the investigator believes may bias or confound the results.","ALL","20 Years","50 Years",{"count":20,"type":21},34,"ESTIMATED","OBSERVATIONAL","Natural Short Sleepers are defined as individuals who sleep fewer than 6 hours per night without any impact on health or daytime mental fatigue levels. Emerging evidence suggests that, in the general population, the gut microbiota would be negatively influenced by this sleep duration. It is possible that Natural Short Sleepers have a distinct gut microbiome. Identifying differences in microbiota composition may lead to an opportunity to improve health outcomes in those with inadequate or poor sleep.",[25],"Short Sleepers",[27,28],"short sleep","short sleepers","RECRUITING","2026-08-06",{"date":32,"type":33},"2026-08-07","ACTUAL",{"date":35,"type":33},"2025-10-23",{"date":37,"type":21},"2027-04",{"name":39,"class":40},"Danisco","INDUSTRY",4,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100611668","night-owl-sleep-study-the-effect-of-sleep-on-fecal-microbiota-100611668","NCT07243574","Night Owl Sleep Study: The Effect of Sleep on Fecal Microbiota","Inclusion Criteria:\n\n1. Men between 20 - 50 years of age and pre-menopausal women between 20 - 45 years of age (inclusive).\n2. Consistent schedule during daytime hours.\n3. BMI 18.5 - 35 kg\u002Fm2 (inclusive).\n4. Good physical and mental health as established by self-reported medical history.\n5. Willingness to maintain and record their general habits, eating, and activity\u002Fexercise pattern for the study period.\n6. Willingness to maintain and record the same time in bed they have during the workdays throughout the habitual workday sleep period.\n7. Able to alter sleeping time during the study intervention period as instructed.\n8. Willingness to maintain typical sleep hygiene patterns (e.g. sleep location, temperature, environment).\n9. Willingness to maintain their current pattern of alcohol consumption for the duration of the study.\n10. Willing and able to participate fully in all aspects of the study and complete all study procedures, including providing signed informed consent.\n11. Completes all study procedures during the 14-day screening period to be eligible for the cohort specific criteria based on the sleep data collected during the screening period.\n12. Has regular bowel habits with bowel movements on at least 5 days a week.\n13. Pittsburgh Sleep Quality Index (PSQI) score ≤10. Note: If PSQI score is between 8 and 10, PI discretion needed to confirm eligibility based on self-report screening diaries and health \\& lifestyle questionnaire.\n\nCohort specific inclusion criteria:\n\nCohort 1 (Insufficient Sleep)\n\nParticipants must meet all general inclusion criteria PLUS:\n\n1. Sleep, on average, 5-7 hours per night on workdays, verified via participant self report during the screening period. Note: Oura ring data from the run-in period will be reviewed to confirm cohort based on PI\u002FSponsor discretion.\n2. Average KSS Score of 6-10 on workdays during the screening period. Note: Use standard rounding rules for averages with decimal places.\n\nCohort 2 (Sufficient Sleep)\n\nParticipants must meet all general inclusion criteria PLUS:\n\n1. Sleep, on average, 7-9 hours per night on workdays, verified via participant self-report during the screening period. Note: Oura ring data from the run-in period will be reviewed to confirm cohort based on PI\u002FSponsor discretion.\n2. Average KSS Score of 1-5 on workdays during screening period. Note: Use standard rounding rules for averages with decimal places.\n\nExclusion:\n\n1. Any current diagnosed or self-reported sleep disorder, including but not limited to sleep apnea, habitual snoring (defined as loud, persistent snoring 3 or more nights per week), insomnia, narcolepsy, and parasomnias.\n2. Any current diagnosed or self-reported gastrointestinal disorder, including Crohn's disease, ulcerative colitis, celiac disease, IBS, or functional bowel disorder or chronic heart burn.\n3. Regularly wakes up during the night 5 or more times per night for a cumulative amount of 30 minutes as observed via self-report during the screening period, per Principal Investigator (PI) discretion.\n4. Currently taking medications (including over-the-counter medications) or dietary supplements that, in the investigator's opinion, may affect the participants' microbiome or sleep.\n5. Have taken in the last 3 months medications (including over-the-counter medications) or dietary supplements that, in the investigator's opinion, may affect the participants' microbiome or sleep.\n6. Neurodegenerative diseases (including multiple sclerosis, Parkinson's disease, Alzheimer's disease, dementia).\n7. Recent history (current use or within the past 1 month) of smoking, vaping or other use of nicotine-containing products.\n8. Recent history (past year) of alcohol abuse or dependence. Defined as regularly drinking more than 12 drinks for females and more than 20 drinks for males per week and based on PI discretion.\n9. Drug abuse or dependence, including consistent recreational substance use such as marijuana.\n10. Binge drinking behavior, defined as 4 or more alcoholic drinks for women or 5 or more alcoholic drinks for men in one sitting on 2 or more occasions, within the past 1 month with final decision per PI discretion.\n11. Diagnosed neuropsychiatric disorders or symptoms possibly affecting sleep (generalized anxiety disorder (GAD), major depressive disorder (MDD), bipolar disorder, schizophrenia)\n12. Any use of systemic antibiotics in the past 3 months. Topical or targeted antibiotic use (eye drop, ear drop) are allowed.\n13. Any use of probiotic supplements in the past 2 weeks.\n14. Any use of proton pump inhibitors (PPIs) in the past 2 weeks.\n15. Pregnant or breastfeeding or planning to become pregnant.\n16. Personal life situation causing stress or challenges in sleep (eg. caretaker required to wake up during sleep, major change in personal life). Note: Life situations causing stress or challenges in sleep that are considered short-term, per PI discretion, may be considered for re-screening 4 weeks after the life situation has resolved, meaning it is no longer causing stress or challenges in sleep.\n17. Planned overnight or cross time zone travel during the study.\n18. Females experiencing perimenopausal or menopausal symptoms, or those who have been diagnosed as perimenopausal or menopausal by a physician.\n19. Any diagnosed condition or undiagnosed symptom which disrupts sleep, including, but not limited to, hyperthyroidism, night sweats, restless legs, or poorly controlled allergic rhinitis.\n20. Extreme chronotypes for Cohort 2 (Sufficient Sleep); those that regularly go to sleep prior to 08:00 pm or after 2:30 am on 3 or more nights a week.\n21. Extreme chronotypes for Cohort 1 (Insufficient Sleep); those that regularly go to sleep prior to 08:00 pm on 3 or more nights a week.\n22. Varying work schedule and\u002For shift workers who work overnight shifts (e.g. 3rd shift, working late night to early morning hours)\n23. Any other personal or medical condition that the investigator believes may bias or confound the results.",true,"40 Years",{"count":51,"type":21},174,"INTERVENTIONAL",[54],"NA","The goal of this clinical trial is to assess differences in the fecal microbiota and metabolome associated with insufficient and sufficient sleep, and to evaluate the response and recovery of the microbiota to changes in participant sleep profiles.\n\nResearchers will compare the effect of sleep intervention on both insufficient and sufficient sleepers to identify differences in fecal microbiota structure and function between cohorts during habitual sleep and during the sleep alteration intervention period..\n\nParticipants will be assigned to one of two cohorts based on their current sleep habits. Cohort 1 are participants who have insufficient sleep at baseline; this cohort will be assigned to spend 1.5 hours more in bed per night. Cohort 2 are participants who have sufficient sleep at baseline; this cohort will be assigned to spend 1.5 hours less in bed per night. The sleep intervention lasts for 14 days.",[57],"Sleep",{"date":32,"type":33},{"date":60,"type":33},"2025-09-17",{"date":62,"type":21},"2027-02",{"name":39,"class":40},3,""]